Catheterization and interventional procedures, such as angioplasty or stenting, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guide wire may be advanced through the needle and into the patient's blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator. A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. The introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure. Upon completing the procedure, the devices and introducer sheath are usually removed, leaving a puncture site in the vessel wall.
Traditionally, external pressure was applied to the puncture site until clotting and wound sealing occurred. In addition, the patient typically remained bedridden for a substantial period of time after clotting to ensure closure of the wound. This procedure was typically time consuming and expensive, and often required as much as an hour of a physician's or nurse's time. It was also uncomfortable for the patient, and required that the patient remain substantially immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma existed from bleeding before hemostasis occurs.
Various medical devices have been utilized in order to close and seal the puncture site in the vessel wall. These medical devices have varied in configuration as well as in the closure device that actually closes the puncture site. The closure devices have ranged from clips that function similar to staples, to patches, and to plugs that occlude the puncture site. While the medical devices and corresponding closure devices have been successful to a certain degree, the functionality and operability of these medical devices has remained tedious and difficult. The various actuating members and modes of actuation that must be operated or controlled are difficult for a single person to perform. For example, a clip applier may be configured to successfully close a puncture site in a vessel wall; however, the operability of the clip applier may be difficult to control and require an enormous amount of manual dexterity.